Fred's Medicated Callus Removers

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Fred’s Stores of Tennessee, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALICYLIC ACID- medicated callus removers patch 
Fred’s Stores of Tennessee, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Fred's Medicated Callus Removers

Active ingredient

Salicylic acid 40%

​Purpose

Callus remover

​Uses

  • for the removal of calluses
  • relieves pain by removing calluses

​Warnings

​For external use only.

​Do not use

  • if you are a diabetic
  • if have poor blood circulation
  • on irritated skin, on any area that is infected or reddened

​Stop use and ask a doctor if

discomfort persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

  • wash affected area and dry thoroughly
  • if necessary, cut medicated patch to fit callus
  • apply adhesive side down of medicated patch onto callus
  • cover medicated patch with pad
  • after 48 hours, remove medicated patch
  • repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)
  • may soak callus in warm water for 5 minutes to assist in removal

Other information

store between 15° and 30°C (59° and 86°F)

​Inactive ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

​Questions?

Call 1-866-964-0939

Principal Display Panel

fred's Pharmacy

Medicated

Callus

Removers

SALICYLIC ACID

  • Callus Removal Treatment
  • Protects Against Pressure & Pain

6 PADS

4 MEDICATED PATCHES

callus remover

SALICYLIC ACID 
medicated callus removers patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55315-377
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 mg  in 4 
Inactive Ingredients
Ingredient NameStrength
POLYVINYL ALCOHOL (UNII: 532B59J990)  
VINYL ACETATE (UNII: L9MK238N77)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55315-377-044 in 1 PACKAGE; Type 0: Not a Combination Product12/19/201709/24/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F12/19/201709/24/2019
Labeler - Fred’s Stores of Tennessee, Inc (005866116)

Revised: 9/2019
 
Fred’s Stores of Tennessee, Inc